DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: figure 6C does not include “262A” ) mentioned in the description in Para. [0089].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“…The example second example actuation device…” in para. [0088] needs to be corrected. A suggested correction is – The [[example]] second example actuation device --.
“…The example third example actuation device…” in para. [0089] needs to be corrected. A suggested correction is – The [[example]] third example actuation device --.
“silicon” in [0078] needs to be corrected. A suggested correction is –[[ silicon ]] silicone--.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Following claims are objected to because of the following informalities:
Claim 18 line 10 “in response to in response to a release of the compression of the bulb” needs to be corrected to --
Claim 18 line 4-5 “the first valve is closed prevent fluid in the bulb from flowing into the supply tube” needs to be corrected to --the first valve is closed to prevent fluid in the bulb from flowing into the supply tube--.
Each of claims 9-10, 15, 17 recite “so as to” encompassing limitations which need to be corrected. A suggested correction is replacing “so as to” with – [[so]] in a manner as to-- to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation proceeding “so as to” necessarily follows from preceding limitations and thus unclear as to whether this limitation is even required or not required. For example amending claim 17 lines 17-18 “at least one arm extending radially inward, into the housing, from the button portion, so as to selectively contact the third valve” to -- at least one arm extending radially inward, into the housing, from the button portion, [[so]] in a manner as to selectively contact the third valve--. Similar amendments are suggested for each of claims 9-10, 15.
Each of claims 1, 5-6, 8, 11, 18-19 recites at least one or more “in response to” encompassing limitations which need to be corrected. A suggested correction is replacing “in response to” with – based upon-- to avoid intended result/functional limitation interpretation (see MPEP 2111.04) which would raise question as to whether the limitation conditioned on “in response to” necessarily follows/occurs and thus unclear as to whether this limitation is even required or not required. For example amending claim 1 lines 7-11 “a fluid flow control system provided on the housing and configured to provide for fluid flow from the fluid reservoir to the inflatable member in a first mode of operation in response to an input at a first fluid flow control device of the fluid flow control system, and for fluid flow from the inflatable member to the fluid reservoir in a second mode of operation in response to an input at a second fluid flow control device of the fluid flow control system” to -- a fluid flow control system provided on the housing and configured to provide for fluid flow from the fluid reservoir to the inflatable member in a first mode of operation based upon an input at a first fluid flow control device of the fluid flow control system, and for fluid flow from the inflatable member to the fluid reservoir in a second mode of operation based upon an input at a second fluid flow control device of the fluid flow control system --. Similar amendments are suggested for each of claims 5-6, 8, 11, 18-19.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 15-16 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention for the following reasons:
Claim 15 recites “an inner wall and an outer wall defining an inflation tube that extends longitudinally along the intermediate portion of the housing” which renders this claim unclear. More specifically, it is unclear as to which preceding structure or combination and permutations of preceding structures “inner wall” and/or “an outer wall” and/or “an inflation tube” extends longitudinally along the intermediate portion of the housing.
Claim 16 recites the limitation "the inner wall". There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Claims terms where relevant are being interpreted in light of definitions enumerated in instant application specification as-filed para. [0053-0055], [0093].
Please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.").
The limitations in claims are being broadly and reasonably interpreted as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Trick (Pub. No.: US 4369771 A, hereinafter referred to as “Trick”).
As per independent Claim 1, Trick discloses an implantable fluid operated inflatable device (Trick in at least abstract, figures 1-2, 5-7, col. 1 lines 4-7, 48-68, col. 25 for example discloses relevant subject-matter. Here, the limitations in claims are being broadly and reasonably interpreted as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. More specifically, Trick in fig. 1-2, col. 1 lines 5-7 and lines 49-57 for example discloses implantable fluid operated inflated device. See Trick col. 1 lines 49-57 “implantable pressurizable penile erectile system which includes … which automatically opens when a predetermined hydraulic pressure is exceeded in the system and which also can be manually operated from the outside to deflate or depressurize the system.” ), comprising:
a housing (Trick, fig. 1, implant 11 housing); a fluid reservoir (Trick, fig. 1, col. 3 lines 30-35 , “outer chamber 18”) received in the housing; an inflatable member (Trick, fig. 1, col. 3 lines 30-35 , “inner chamber 17”) received in the housing; fluidics components (Trick, fig. 5, col. 3 line 49-col. 4 line 48, valves (21,24, 29), and fluid passages (22, 26, 26’, 27) and fluid ports/exits such as 28, 31, 32) provided in the housing, the fluidics components providing for fluid communication between the fluid reservoir and the inflatable member (Trick, fig. 5-7, col. 3 lines 49-col. 4 lines 4 “There is a passage 22 in the distal tip portion 14 of the implant 11 which leads from the outer chamber 18 to the pumping chamber 23 of the pump 19… when the wall of the pump 20 is squeezed as shown in FIG. 5 the fluid pressure in the pumping chamber 23 and passage 27 exceeds that in chamber 17 and the edges of the check valve 29 are deflected allowing fluid to flow about the check valve 29 into chamber 17”; col. 4 line 66-col. 5 line 7 “valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34…As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18”); and
a fluid flow control system (fig. 5-7) provided on the housing and configured to provide for fluid flow from the fluid reservoir to the inflatable member in a first mode of operation (Trick fig. 5) in response to an input at a first fluid flow control device of the fluid flow control system (Trick, fig. 5, col. 3 lines 49-col. 4 lines 31 “when the wall of the pump 20 is squeezed as shown in FIG. 5 the fluid pressure in the pumping chamber 23 and passage 27 exceeds that in chamber 17 and the edges of the check valve 29 are deflected allowing fluid to flow about the check valve 29 into chamber 17… The implant 11 is pressurized by sequentially squeezing the resilient wall 20a of the pump 20 to force the hydraulic fluid 19 from the pumping chamber 23 into non-distensible inner chamber 17 under pressure and then allowing the wall 20a to assume its normal shape… When the chamber 17 is sufficiently pressurized and rigid, the pumping is stopped … chamber 17 remains filled, pressurized and rigid, as seen in FIG. 2… If desired, the filling and pressurizing of the non-distensible inner chamber 17 may be facilitated by manually squeezing the penis to help force fluid 19 which is in chamber 18 through the passage 22, past the flap valve 24 and into the pumping chamber 23”), and for fluid flow from the inflatable member to the fluid reservoir in a second mode of operation (Trick, fig. 6-7) in response to an input at a second fluid flow control device (Trick, fig. 6-7) of the fluid flow control system (Trick, fig. 6-7, col. 3 lines 49-col. 4 lines 31 “chamber 17 remains filled, pressurized and rigid, as seen in FIG. 2, until the pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1.”).
As per dependent Claim 2, Trick further discloses implantable fluid operated inflatable device wherein the implantable fluid operated inflatable device is a penile prosthesis (Trick, fig. 1-2, col. 1 lines 5-7 “inflatable, implantable penile erectile system”), including: a proximal tip (Trick, fig. 1, col. 3 lines 4-6, tip at implant 11 proximal stem portion 12) at a first end portion of the housing; a distal tip at (Trick, fig. 1, col. 3 lines 4-6, tip at distal tip portion 14) a second end portion of the housing; and an inflatable portion corresponding to the inflatable member, at an intermediate portion of the housing (Trick, fig. 2, col. 3 col. 3 lines 14-19, lines 31-44, an intermediate cylindrical portion 13 in fluid pressurized state).
As per dependent Claim 3, Trick further discloses implantable fluid operated inflatable device wherein the first fluid flow control device includes a malleable bulb (Trick, fig. 5, col. 3 lines 66- col. 4 lines 44, “pump 20”) provided in the distal tip; and the second fluid flow control device includes a valve actuation device (Trick fig. 1, 6-7, col. 4 lines 45-col. 5 line 34. See at least fig. 6-7 col. 4 lines 45-col. 5 12 “pressure control valve 21 may be manually opened… valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34”) provided at the intermediate portion of the housing.
As per dependent Claim 4, Trick further discloses implantable fluid operated inflatable device wherein the fluidics components (Here, the limitations in claims are being broadly and reasonably interpreted as encompassing both indirect/direct interactions, arrangement, associations, and/or linkages) include: a supply tube (Trick, fig. 5, col. 3 line 45-65 “22”; col. 3 line 45-65 “a passage 22 in the distal tip portion 14 of the implant 11 which leads from the outer chamber 18 to the pumping chamber 23 of the pump... Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough”) connecting the fluid reservoir and a bulb positioned in the distal tip;
a first valve (Trick fig. 5, “valve 24”; col. 3 line 45-55 “the exit of the passage 22 is closed by a one way flap valve 24”) positioned in the supply tube; a port (Trick fig. 5, “exit 28”) connecting the bulb to the inflatable member;
a second valve (Trick, fig. 5, “29”) positioned at the port connecting the bulb to the inflatable member; a fluid passageway (Trick, fig. 5-7, fluid passageway formed between inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18) connecting the inflatable member and the fluid reservoir (Trick, fig. 5-7, col. 4 lines 49-col. 5 line 7 “an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18… fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18”); and
a third valve (Trick, fig. 1, 6-7, “21”, col. 4 lines 49-68 “Positioned between the inlet 31 and the outlet 32 is a valve housing 33”) positioned in the fluid passageway at least indirectly connecting the inflatable member and the fluid reservoir.
As per dependent Claim 5, Trick further discloses implantable fluid operated inflatable device of claim 4, wherein the first fluid flow control device includes the bulb (Trick fig. 1, fig. 5, pump 20/bulb) provided in the distal tip, and wherein, in response to a first manipulation of the bulb positioned in the distal tip (Trick, fig. 5, col. 3 lines 66-col. 4 line 6 “when the wall of the pump 20 is squeezed as shown in FIG. 5”, col. 4 lines 35-44 “the filling and pressurizing of the non-distensible inner chamber 17 may be facilitated by manually squeezing the penis to help force fluid 19 which is in chamber 18 through the passage 22, past the flap valve 24 and into the pumping chamber 23”;): the first valve is closed to prevent fluid in the bulb from flowing into the supply tube; the second valve is opened to allow fluid held in the bulb to flow from the bulb to the inflatable member to inflate the inflatable member; and the third valve is closed to prevent fluid from flowing from the inflatable member to the fluid reservoir (Trick fig. 1, 5-7 col. 3 line 66-col. 4 line 65 “when the wall of the pump 20 is squeezed as shown in FIG. 5 the fluid pressure in the pumping chamber 23 and passage 27 exceeds that in chamber 17 and the edges of the check valve 29 are deflected allowing fluid to flow about the check valve 29 into chamber 17 … When the pump wall 20a is first squeezed the fluid 19 originally in the pumping chamber 23 is forced through the axial passages 26, 26' and longitudinal passage 27 out the exit 28 forcing the edges of the check valve 29 off their seat allowing the fluid 19 to flow about the valve 29 into the chamber 17 (as shown by the arrows in FIG. 5). The increased pressure in the pumping chamber 23 keeps the flap valve 24 seated closing passage 22 and preventing flow into chamber 18… Whenever the pressure in pumping chamber 23 equals or exceeds that in chamber 18 the flap valve 24 is seated closing the passage 22. When the chamber 17 is sufficiently pressurized and rigid, the pumping is stopped whereby the exit 28 of the passage 27 is closed by pressure of the fluid 19 in chamber 17 upon the outer surface 29a on the enlarged head of the check valve 29… pump should be of the type which opens which it is squeezed and automatically closes when the squeezing stops… sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa”).
As per dependent Claim 6, Trick further discloses implantable fluid operated inflatable device wherein in response to a second manipulation of the bulb positioned in the distal tip (Trick, fig. 1-2, col. 4 lines 25- 45 “pump should be of the type which … closes when the squeezing stops”): the first valve is opened to allow fluid to flow from the supply tube into the bulb to refill the bulb; the second valve is closed to prevent flow of fluid from the bulb into the supply tube; and the third valve is closed to prevent fluid from flowing from the inflatable member to the fluid reservoir (Trick, fig. 1-2, fig. 5-7, col. 3 fig. 5-7 col. 3 line 31-col. 4 line 65 “As seen in FIGS. 1 and 3, when the implant 11 is in a non-pressurized state both the chambers 17 and 18 are substantially filled with a non-compressible hydraulic fluid 19… As seen therein the exit of the passage 22 is closed by a one way flap valve 24 which only opens when the fluid pressure in the passage 22 exceeds that in the pumping chamber 23… The check valve 29 is normally kept seated closing the passage 27 by fluid pressure in chamber 17… Thereafter, when the wall 20a is allowed to assume its normal position, a reduced pressure is formed in the pumping chamber 23 and as a result the flap valve 24 is moved off its seat allowing fluid 19 to flow from chamber 18 into the pumping chamber 23… the pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1… pump should be of the type which … automatically closes when the squeezing stops”).
As per dependent Claim 7, Trick further discloses implantable fluid operated inflatable device wherein the first manipulation of the bulb is a compression of the bulb (Trick, fig. 5, col. 3 lines 66-col. 4 line 6 “when the wall of the pump 20 is squeezed as shown in FIG. 5”, col. 4 lines 35-44 “the filling and pressurizing of the non-distensible inner chamber 17 may be facilitated by manually squeezing the penis to help force fluid 19 which is in chamber 18 through the passage 22, past the flap valve 24 and into the pumping chamber 23”;) and the second manipulation is a release of the compression of the bulb (Trick, fig. 1-2, col. 4 lines 25- 45 “pump should be of the type which … closes when the squeezing stops”).
As per dependent Claim 8, Trick further discloses implantable fluid operated inflatable device wherein the second fluid flow control device includes a valve actuation device (Trick, fig. 1, -2, fig. 6-7, “pressure control valve 21”) provided at the intermediate portion of the housing, and wherein, in response to a manipulation of the valve actuation device: the third valve is opened to allow fluid to flow from the inflatable member to the fluid reservoir to deflate the inflatable member; the first valve is closed prevent fluid in the bulb from flowing into the supply tube; and the second valve is closed to prevent fluid held in the bulb from flowing to the inflatable member (Trick in at least fig. 1-2, fig. 5-7, col. 4 line 30-col. 5 line 12 “pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1…pressure control valve 21 may be manually opened …the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33… force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34…fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 9, Trick further discloses implantable fluid operated inflatable device wherein the valve actuation device includes: a button portion (Trick fig. 6-7, poppet 34 ) provided in a recess (Trick fig. 6-7, housing 33) formed in an outer peripheral surface of the housing (Here, the claim term “outer” is being broadly yet reasonably interpreted as “exterior” of housing i.e. no embedded withing housing walls. Fig. 1-2, 6-7); and at least one arm (Trick fig. 6-7, sharp edge 38) extending radially inward, into the housing, from the button portion, so as to selectively contact the third valve (Trick, fig. 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 10, Trick further discloses implantable fluid operated inflatable device wherein, in an unactuated state of the valve actuation device: the third valve is positioned so as to close the fluid passageway between the inflatable member and the fluid reservoir (Trick, fig. 1, 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 11, Trick further discloses implantable fluid operated inflatable device of claim 9, wherein, in an actuated state of the valve actuation device: the at least one arm is moved radially inward in response to a depression of the button portion; the third valve moves to open the fluid passageway between the inflatable member and the fluid reservoir in response to a force exerted on the third valve by the at least one arm; and fluid flows from the inflatable member to the fluid reservoir to deflate the inflatable member (Trick, fig. 1, 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 12, Trick further discloses implantable fluid operated inflatable device wherein the third valve is oriented axially within the housing (Trick fig. 1-2, 5-7), wherein the at least one arm is configured to exert a radial force on the third valve that moves the third valve in an axial direction to open the fluid passageway between the inflatable member and the fluid reservoir (Trick, fig. 1, 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 13, Trick further discloses implantable fluid operated inflatable device wherein the third valve is oriented radially within the housing, and wherein the at least one arm is configured to exert a radial force on the third valve that moves the third valve in a radial direction to open the fluid passageway between the inflatable member and the fluid reservoir (Trick, fig. 1, 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 14, Trick further discloses implantable fluid operated inflatable device wherein the button portion includes one of: a ring-shaped button arranged in the recess, extending around the intermediate portion of the housing in which the recess is formed; an arcuate button arranged in the recess, extending partially around the intermediate portion of the housing in which the recess is formed; or a plurality of arcuate buttons arranged in the recess, spaced apart along the intermediate portion of the housing in which the recess is formed (Trick fig. 5-7, “34”, col. 4 lines 49-65 “a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33”).
As per dependent Claim 15, Trick further discloses implantable fluid operated inflatable device wherein the inflatable member includes: an inner wall (Trick, fig. 1, sleeve 15. Col. 3 lines 24-20 “intermediate cylindrical portion 13 of the implant 11 preferably includes a pair of concentric cylindrical sleeves 15 and 16”) and an outer wall (Trick, fig. 1, sleeve 16. Col. 3 lines 24-20 “intermediate cylindrical portion 13 of the implant 11 preferably includes a pair of concentric cylindrical sleeves 15 and 16) defining an inflation tube that extends longitudinally along the intermediate portion of the housing (Trick, Col. 3 lines 24-25 “intermediate cylindrical portion 13 of the implant 11 preferably includes a pair of concentric cylindrical sleeves 15 and 16 … to form a pair of concentric chambers 17 and 18, respectively… The sleeve 15 cooperates with the sleeve 16 which is spaced outwardly from the sleeve 15 to form the outer chamber 18”); a plurality of first openings (Trick, fig. 5 col. 3 lines 56-63 “Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough. The support member 25 extends from and provides communication between the hollow interior 14a of the conical tip 14, the pumping chamber 23 and the inner chamber 17. The end of the passage 27 opposite the conical tip 14 has an enlarged exit 28 “) formed between the inner wall and the outer wall, extending longitudinally along a length of the inflatable member; and a plurality of second openings (Trick, fig. 1, fig. 5, col. 3 lines 56-63 “Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough. The support member 25 extends from and provides communication between the hollow interior 14a of the conical tip 14, the pumping chamber 23 and the inner chamber 17. The end of the passage 27 opposite the conical tip 14 has an enlarged exit 28 “) formed between the inner wall and the outer wall, alternately arranged with the plurality of first openings, extending longitudinally along the length of the inflatable member, wherein, in an inflated state of the inflatable member, the plurality of first openings and the plurality of second openings are configured to be filled with fluid so as to inflate the inflatable member (Trick fig. 5 see fluid line arrows. Col. 3 line 56-col. 4 line 4 “Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough… end of the passage 27 opposite the conical tip 14 has an enlarged exit 28 … when the wall of the pump 20 is squeezed as shown in FIG. 5 the fluid pressure in the pumping chamber 23 and passage 27 exceeds that in chamber 17 and the edges of the check valve 29 are deflected allowing fluid to flow about the check valve 29 into chamber 17 as indicated by the arrows”).
As per dependent Claim 16, Trick further discloses implantable fluid operated inflatable device wherein the inner wall defines a central opening (Trick fig. 5 col. 3 lines 56-58 “a longitudinal passage 27 extending therethrough.”) extending longitudinally along a length of the inflatable member, wherein at least some of the fluidics components are received within a space defined by the central opening (Trick fig. 5).
As per independent Claim 17, Trick discloses a fluid flow control system for an implantable fluid operated inflatable device (Trick in at least abstract, figures 1-2, 5-7, col. 1 lines 4-7, 48-68, col. 25 for example discloses relevant subject-matter. Here, the limitations in claims are being broadly and reasonably interpreted as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. More specifically, Trick in fig. 1-2, fig. 5-7, col. 1 lines 5-7 and lines 49-57 for example discloses fluid flow control system (fig. 5-7) for an implantable fluid operated inflatable device as seen in fig. 1-2. See Trick col. 1 lines 49-57 “implantable pressurizable penile erectile system which includes … which automatically opens when a predetermined hydraulic pressure is exceeded in the system and which also can be manually operated from the outside to deflate or depressurize the system.”), comprising:
a housing (Trick, fig. 1, implant 11 housing);
a first fluid flow control device (fig. 5-7) provided at a distal end portion (Trick, fig. 1, col. 3 lines 4-6, distal end portion 14) of the housing, the first fluid flow control device including: a bulb (Trick, fig. 5, col. 3 lines 66- col. 4 lines 44, “pump 20”) provided in distal tip (Trick, fig. 1, col. 3 lines 4-6, tip at distal tip portion 14) defining the distal end portion of the housing;
a first valve (Trick fig. 5, “valve 24”; col. 3 line 45-55 “the exit of the passage 22 is closed by a one way flap valve 24”) positioned in a supply tube (Trick, fig. 5, col. 3 line 45-65 “22”; col. 3 line 45-65 “a passage 22 in the distal tip portion 14 of the implant 11 which leads from the outer chamber 18 to the pumping chamber 23 of the pump... Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough”) connecting the bulb with a fluid reservoir (Trick, fig. 1, col. 3 lines 30-35 , “outer chamber 18”); and
a second valve (Trick, fig. 5, “29”) positioned in a port (Trick fig. 5, “exit 28”) connecting the bulb and an inflatable member (Trick, fig. 1, col. 3 lines 30-35 , “inner chamber 17”. TRICK col. 3 lines 56-65 “Positioned within the pumping chamber 23 is a support member 25 which has axial passages 26, 26' and a longitudinal passage 27 extending therethrough. The support member 25 extends from and provides communication between the hollow interior 14a of the conical tip 14, the pumping chamber 23 and the inner chamber 17. The end of the passage 27 opposite the conical tip 14 has an enlarged exit 28 in which there is positioned an umbrella type flexible check valve 29”);
a second fluid flow control device (Trick, fig. 5-7, col. 3 lines 49-col. 4 lines 31 “chamber 17 remains filled, pressurized and rigid, as seen in FIG. 2, until the pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1.”) provided at an intermediate portion (Trick, fig. 2, col. 3 col. 3 lines 14-19, lines 31-44, an intermediate cylindrical portion 13) of the housing, the second fluid flow control device including:
a valve actuation device (Trick fig. 5-6) configured to selectively actuate a third valve (Trick, fig. 6-7, “21”, col. 4 lines 49-68 “Positioned between the inlet 31 and the outlet 32 is a valve housing 33”) provided in a fluid passageway connecting the inflatable member and the fluid reservoir,
the valve actuation device including: a button portion (Trick fig. 6-7, poppet 34 ) provided in a recess (Trick fig. 6-7, housing 33) formed in an outer peripheral surface of the housing (Here, the claim term “outer” is being broadly yet reasonably interpreted as “exterior” of housing i.e. no embedded withing housing walls. Fig. 1-2, 6-7); and at least one arm (Trick fig. 6-7, sharp edge 38) extending radially inward, into the housing, from the button portion, so as to selectively contact the third valve(Trick, fig. 6-7, col. 4 line 45-col. 5 line 12 “the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33. As seen in FIG. 6, the poppet 34 which has an annular seal 36 positioned about the stem 35 is supported within the housing 33 by a preloaded spring 37 so that the sharp edge 38 of the seal 36 bears against the flat under surface of a flange 39 which partially closes the top of the housing 33. The force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34. Further movement of the jacket 31 causes the poppet 34 to move towards the spring 37 and the seal edge 38 to move from sealing engagement with the underside 39a of the flange 39 of the housing 33 as seen in FIG. 7. As a result, fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 18, Trick further discloses fluid flow control system wherein, in a first mode of operation (Trick, fig. 5) of the implantable fluid operated inflatable device, in response to a compression of the bulb (Trick fig. 5, col. 3 lines 66-col. 4 line 6 “when the wall of the pump 20 is squeezed as shown in FIG. 5”, col. 4 lines 35-44 “the filling and pressurizing of the non-distensible inner chamber 17 may be facilitated by manually squeezing the penis to help force fluid 19 which is in chamber 18 through the passage 22, past the flap valve 24 and into the pumping chamber 23”) positioned in the distal tip: the first valve is closed prevent fluid in the bulb from flowing into the supply tube; the second valve is opened to allow fluid held in the bulb to flow from the bulb to the inflatable member to inflate the inflatable member; and the third valve is closed to prevent fluid from flowing from the inflatable member to the fluid reservoir (Trick fig. 5-7 col. 3 line 66-col. 4 line 65 “when the wall of the pump 20 is squeezed as shown in FIG. 5 the fluid pressure in the pumping chamber 23 and passage 27 exceeds that in chamber 17 and the edges of the check valve 29 are deflected allowing fluid to flow about the check valve 29 into chamber 17 … When the pump wall 20a is first squeezed the fluid 19 originally in the pumping chamber 23 is forced through the axial passages 26, 26' and longitudinal passage 27 out the exit 28 forcing the edges of the check valve 29 off their seat allowing the fluid 19 to flow about the valve 29 into the chamber 17 (as shown by the arrows in FIG. 5). The increased pressure in the pumping chamber 23 keeps the flap valve 24 seated closing passage 22 and preventing flow into chamber 18… Whenever the pressure in pumping chamber 23 equals or exceeds that in chamber 18 the flap valve 24 is seated closing the passage 22. When the chamber 17 is sufficiently pressurized and rigid, the pumping is stopped whereby the exit 28 of the passage 27 is closed by pressure of the fluid 19 in chamber 17 upon the outer surface 29a on the enlarged head of the check valve 29… pump should be of the type which opens which it is squeezed and automatically closes when the squeezing stops… sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa”); and
in response to in response to a release of the compression of the bulb positioned in the distal tip (Trick, fig. 1-2, col. 4 lines 25- 45 “pump should be of the type which … closes when the squeezing stops”): the first valve is opened to allow fluid to flow from the supply tube into the bulb to refill the bulb; the second valve is closed to prevent flow of fluid from the bulb into the supply tube; and the third valve is closed to prevent fluid from flowing from the inflatable member to the fluid reservoir (Trick, fig. 1-2, fig. 5-7, col. 3 fig. 5-7 col. 3 line 31-col. 4 line 65 “As seen in FIGS. 1 and 3, when the implant 11 is in a non-pressurized state both the chambers 17 and 18 are substantially filled with a non-compressible hydraulic fluid 19… As seen therein the exit of the passage 22 is closed by a one way flap valve 24 which only opens when the fluid pressure in the passage 22 exceeds that in the pumping chamber 23… The check valve 29 is normally kept seated closing the passage 27 by fluid pressure in chamber 17… Thereafter, when the wall 20a is allowed to assume its normal position, a reduced pressure is formed in the pumping chamber 23 and as a result the flap valve 24 is moved off its seat allowing fluid 19 to flow from chamber 18 into the pumping chamber 23… the pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1… pump should be of the type which … automatically closes when the squeezing stops”).
As per dependent Claim 19, Trick further discloses fluid flow control system wherein, in a second mode of operation (Trick fig. 6-7) of the implantable fluid operated inflatable device, in response to a depression of the button portion (Trick fig. 6-7, col. 4 line 66-col. 5 line 2 “The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34”) of the second fluid flow control device: the third valve is opened to allow fluid to flow from the inflatable member to the fluid reservoir in response to a force exerted on the third valve by the arm portion, to deflate the inflatable member; the first valve is closed prevent fluid in the bulb from flowing into the supply tube; and the second valve is closed to prevent fluid held in the bulb from flowing to the inflatable member (Trick in at least fig. 1-2, fig. 5-7, col. 4 line 30-col. 5 line 12 “pressure control valve 21 is opened to allow fluid 19 to flow back to the chamber 18 whereupon the implant 11 resumes a non-pressurized state as seen in FIG. 1…pressure control valve 21 may be manually opened …the pressure control valve 21 includes an outer jacket 30 having an inlet 31 which communicates with the inner chamber 17 and an outlet 32 which leads to the outer chamber 18. Positioned between the inlet 31 and the outlet 32 is a valve housing 33. A poppet 34 having a stem 35 is movably mounted in the housing 33… force of the spring 37 on the underside of the poppet 34 normally keeps the sharp edge 38 of the seal 36 in fluid tight contact with the flat underside 39a of the flange 39 so that the valve 29 is closed and no fluid can flow from the inlet 31 to the outlet 32 or vice versa…The valve 21 can be opened to permit fluid to flow from the chamber 17 to the chamber 18 by manually exerting a pressure on the jacket 30 at point 30a to cause the jacket 30 to deflect and contact stem 35 of the poppet 34…fluid 19 flows from the pressurized inner chamber 17 to the outer chamber 18. When the deflecting pressure on the jacket 31 and the stem 35 is removed the preloaded spring 37 forces the sharp edge 38 back into sealing arrangement with the flat underside 39a of the flange 39 cutting off flow from the inlet 31 to the outlet 32”).
As per dependent Claim 20, Trick further discloses fluid flow control system wherein the fluid flow control system, the inflatable member and the fluid reservoir are incorporated into a single unit (Trick fig. 1-2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims. US 20060135845 A1; US 20030220539 A1; US 20100036196 A1; US 20030100929 A1; US 4360010 A; US 4364379 A; US 4574792 A; US 4407278 A ; US 4895139 A for disclosing implantable fluid operated penile prosthetic devices similar to that disclosed. US 20030144648 A1; US 20130303841 A1 for disclosing implantable fluid operated devices similar to that disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUNITA REDDY whose telephone number is (571)270-5151. The examiner can normally be reached on M-Thu 10-4 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES A MARMOR II can be reached on (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791
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